Method for vacuum-forming dental appliance

ABSTRACT

An appliance and methods are described that include embodiments of a mandibular advancement or positioning device which can use elastic bands to pull the jaw forward. The appliance has an upper plastic tray conforming to the patient&#39;s upper teeth and including 3D printed sets of retention hooks coupled to the upper plastic tray via being encased in plastic, one on the right and one on the left anterior buccal portion of an upper plastic base. The appliance also has a lower plastic tray conforming to the patient&#39;s lower teeth including mandibular dentition, and includes having a 3D printed bite pad which opens the bite vertically. The lower tray also has a set of 3D printed plastic retention hooks encased in plastic extending outwardly from the teeth, one on the right and one on the left of the posterior buccal portion of the lower plastic base. Elastic bands of different lengths and strengths are attached to both the top and bottom retention hooks on both sides of the trays to pull the mandible forward for treatment.

CROSS-REFERENCE TO RELATED APPLICATIONS

An Application Data Sheet (ADS) has been filed on the filing date ofthis application, it is incorporated by reference herein. Anyapplications claimed on the ADS for priority under 35 U.S.C. §§ 119,120, 121, or 365(c), and any and all parent, grandparent,great-grandparent, etc. applications of such applications, are alsoincorporated by reference, including any priority claims made in thoseapplications and any material incorporated by reference, to the extentsuch subject matter is not inconsistent herewith.

The present application is related to and/or claims the benefit of theearliest available effective filing date(s) from the following listedapplication(s) (the “Priority Applications”), if any, listed below(e.g., claims earliest available priority dates for other thanprovisional patent applications or claims benefits under 35 USC § 119(e)for provisional patent applications, for any and all parent,grandparent, great-grandparent, etc. applications of the PriorityApplication(s)).

The present application constitutes a continuation-in-part of U.S.patent application Ser. No. 14/478,511 Method and Apparatus forVacuum-formed Dental Appliance, naming Donald E. Frantz and Joseph LeeFrantz, as inventors filed Sep., 5, 2014, with attorney docket no.FZ1-0008USC1 which is currently co-pending or is an application of whicha currently co-pending application is entitled to the benefit of thefiling date

application Ser. No. 14/478,511 constitutes a continuation applicationof U.S. patent application Ser. No. 13/520,520, now U.S. Pat. No.8,882,497, Method and Apparatus for Vacuum-formed Dental Appliance,naming Donald E. Frantz and Joseph Lee Frantz, as inventors filed Jul.3, 2012, with attorney docket no. FZ1-0008USP1-PCT-US which applicationis entitled to the benefit of the filing date, which application is anationalization application of PCT/US2011/03067, filed Apr. 21, 2011,pending, which is a non-provisional PCT application of provisionalpatent application filed Mar. 29, 2010, 61/318,662, expired.

FIELD

This invention related generally to oral appliances for preventing or atleast alleviating snoring and sleep apnea.

BACKGROUND OF INVENTION

At the present, there is a need for a viable vacuum formed,non-invasive, inexpensive custom breathing appliance. Most sleep apneaappliances have been made of bulky boil & bite materials. Morespecifically, there is a need for a dental office manufacturing methodutilizing techniques and machines in most dental offices to manufacturea removable mandibular advancement appliance which can use elastic bandsto pull the jaw forward and bite pads to open the bite vertically. Inaddition to the foregoing, other method aspects are described in theclaims, drawings, and text forming a part of the present disclosure.

SUMMARY

An embodiment provides a method of making a trial dental appliance for apatient including temporarily attaching a first set of retention hooksto models of the patient's upper teeth; temporarily attaching a set ofbite pads integrated with a second set of retention hooks to the modelof the patient's lower teeth; vacuum forming sheets of plastic over themodels of the patient's upper and lower teeth with the temporarilyattached first set of retention hooks and the set of bite padsintegrated with the second set of retention hooks in a machine to formupper and lower plastic trays vacuum formed to fit over the teeth of thepatient, the heat from the vacuum machine enabling the sheets of plasticto encase the temporarily attached first set of retention hooks and theset of bite pads integrated with the second set of retention hooks; andremoving the trays from the models with the incased parts such as hooksand bite pads, which can be 3D printed to be patient specific, theremoval of the trays detaching the first set of retention hooks and theset of bite pads integrated with the second set of retention hooks fromthe models to form the dental appliance to enable attachment of a pairof elastic bands to be placed over the first and second sets of encasedretention hooks and bite pads. In addition to the foregoing, othersystem aspects are described in the claims, drawings, and text forming apart of the present disclosure.

An embodiment provides an oral appliance including upper and lower traysadapted to fit tightly but removably over the occlusal surfaces of theupper and lower teeth of a patient; a first set of retention hooksencased by the upper tray; a set of bite pads integrated with a secondset of retention hooks encased by the lower tray to form a bite plane onthe occlusal surface of both sides of the lower tray, each bite padbeing patient-specific and 3D printed and having a bite surface whichprotrudes therefrom so as to engage the occlusal surfaces on the uppertray and thus maintain the occlusal surfaces of the trays inpredetermined spaced relation, when the trays are so fitted; and meansto releasably attach the anterior and posterior portions of both sidesof each tray using the first set of retention hooks and the second setof retention hooks to enable a lower jaw to advance forwardly when theupper and lower trays are fitted over the patient's teeth. In additionto the foregoing, other computer program product aspects are describedin the claims, drawings, and text forming a part of the presentdisclosure.

The foregoing is a summary and thus contains, by necessity,simplifications, generalizations and omissions of detail; consequently,those skilled in the art will appreciate that the summary isillustrative only and is not intended to be in any way limiting. Otheraspects, features, and advantages of the devices and/or processesdescribed herein, as defined by the claims, will become apparent in thedetailed description set forth herein.

BACKGROUND

It is well documented in the literature that an oral appliance thatopens the bite and moves the mandible forward will greatly reduce sleepapnea and snoring. It is also documented that these appliances arecapable of producing considerable discomfort to patients, unwantedmovement of their teeth, and/or tempromandibular joint pain as well asother problems.

A variety of trial oral appliances are available for preventing snoringand sleep apnea. Of these, all are removable, and most advance themandible, generally do not use elastic bands to move the mandibleforward. Bulky “boil & bite” appliances have not been effective and havenot had patient acceptance or compliance. These uncomfortable deviceshave driven patients away from wanting to be treated by a custom oralappliance.

Also, several removable, oral snoring/apnea appliances are adjustable,pulling the jaw forward in different, set percentages of their maximummovement. However, there is a need for patient-specific and adjustableappliances, both in amount of forward movement and vertical opening.Rather than temporary or permanent adjustments to appliances made byeither placing spacers, turning screws, or by grinding away plastic orother material, there is a need for patient-specific advancements thatdo not lock the patient's jaw in one ridged spot causing TMJ pain. Insummary, appliances exist in which the amount of advancement may bechanged, but the changes result in a new fixed position of the mandiblecreating pain and discomfort. An appliance is needed that is easilychanged vertically or caudally in displacement of the mandible toincrease the effectiveness of the appliance.

What is needed is an adjustable oral snoring/sleep apnea appliance whichis effective, which has high patient acceptance, and which will notcause temporomandibular joint problems, unwanted tooth movement orsoreness.

The appliance of the present disclosure greatly reduces, or eliminates,sleep apnea and snoring, while alleviating temporomandibular jointproblems, unwanted tooth movement and soreness, with completeadjustability of the appliance both in the amount of forward movement ofthe lower jaw, and in the amount of vertical bite opening. Anotherobject is a mandibular advancement appliance with high patientacceptance, comfort, and treatment success. Another object is to makethe appliance in a single office visit using machines normally suppliedin a typical dentist's office.

DESCRIPTION OF THE DRAWINGS

A better understanding of the subject matter of the application can beobtained when the following detailed description of the disclosedembodiment is considered in conjunction with the following drawings, inwhich:

FIG. 1 illustrates a dental mold in accordance with an embodiment of thesubject matter of the present application.

FIG. 2 illustrates a dental mold with bite pads temporarily attachedthereon in accordance with an embodiment of the subject matter of thepresent

FIG. 3 illustrates a top view of a dental appliance in accordance withan embodiment of the subject matter of the present application.

FIG. 4 illustrates a vacuum forming device forming plastic to a dentalmold in accordance with an embodiment of the subject matter of thepresent application.

FIGS. 5 and 6 illustrate a retention hook encased in plastic as part ofa dental appliance in accordance with an embodiment of the subjectmatter of the present application.

FIG. 7 is a flow diagram illustrating a method in accordance with anembodiment of the subject matter of the present application.

DETAILED DESCRIPTION

Embodiments herein relate to methods for manufacturing an oral appliancethat requires only a single office visit.

During the office visit, a patient can be fitted for an oral applianceby first obtaining an upper (maxillary) and lower (mandibular)impression of the teeth and supporting soft tissue including the upperhard palate. This impression must be extremely accurate to avoid toothsoreness, and/or movement when the appliance is placed in the patient'smouth. The impression is taken by: (1) having the patient rinse with apre-impression mouth wash to eliminate any saliva distortion; and (2)pouring the impressions immediately to avoid distortion using a hard labstone.

In an alternate embodiment, instead of taking impressions, a patient canbe visually examined with high definition optics capable of generating3D images and Computer Aided Design (CAD) images. For example, 3D x-rayscan be converted to CAD images that accurately portray the sameinformation that impressions could produce. Due to the speed at whichCAD images can be collected, it is possible that CAD images are moreaccurate than the impressions requiring prolonged setting time requiredof the plaster involved with impressions.

The impressions and/or CAD images are used to make a model of thepatient's teeth. The model is then altered by temporarily attaching afirst set of retention hooks to the model of the patient's upper teeth.The attachment can be by dental wax, glue, such as a polymer glue orSuper Glue.

In one embodiment either or both the bite pads and retention hooks arecreated via CAD images and 3D printed.

Digital dentistry is quickly becoming a staple for dental treatmentsamong discerning dental professionals. 3D printed models arecost-effective for confirming oral topography via inta-oral orimpression scans. Several companies now can use machines to create 3Dmodel solutions for making impressions.

The retention hooks which can be 3D printed and patient specific, areplaced between the cuspid and first bicuspid on the upper model. Next,with the upper models held in centric occlusion with the lower model, ameasuring device applied to the upper retention hook and with a finepoint “sharpie” pen scribe a mark on the lower model 23, 25, or 27mmdepending on the size of the patient's dental arch. According to anotherembodiment, using CAD images or the like, measuring the placement of the3D printed retention hooks can be accomplished digitally at 23, 25, 27mm or other more exact placements.

When temporarily attaching the 3D printed lower bite pads integratedwith the second set of retention hooks, the scribed line (which can begenerated automatically via CAD images) on the lower model can be underthe center of the second set of 3D printed retention hooks and the topportion of the 3D printed bite pad should be level with the bite pad onthe opposite side of the arch. In one embodiment, the lower bite padsintegrated with retention hooks are determined via a CAD image(s) and 3Dprinted. For example, a CAD image can create maximal and minimalmeasurements for the lower 3D printed bite pads. In one embodiment, thedisplacement can be 23, 25 or 27 millimeters displaced from the firstset of retention hooks, measured from center to center.

Likewise, the model, either digital or via plaster, can be altered bytemporarily attaching a second set of 3D printed bite pads integratedwith a 3D printed second set of retention hooks to the 3D printed modelof the patient's lower teeth.

Next, a method employs a machine typically seen in a dentist's office,such as a thermo-plastic machine shown in FIG. 3. The dentist can placesheets of plastic in the machine so that upon heating and applyingvacuum, the sheets are pulled down over the 3D models of the patent'supper and lower teeth with the temporarily attached first set of 3Dprinted retention hooks and the set of 3D printed bite pads integratedwith the 3D printed second set of retention hooks. The machine canoperate on the upper and lower teeth models separately, as will beappreciated by those skilled in the art.

The plastic forms upper and lower plastic trays adapted to fit over theteeth of the patient with the 3D printed retention hooks and 3D printedbite pads encased by the plastic. In one embodiment, the 3D printed bitepads are intended to create an 8 mm anterior vertical opening, which canbe according to specific patient requirments in accordance with images.Information is obtained from the patient as to any pressures on theteeth or gingiva. Also, the appliance is checked for comfort of andevenness of opening from side to side with the patient. If pressures arefelt by the patient on any tooth or any area of the gingiva, then theseareas must be carefully relieved. The only reasons there would bepressure on the teeth or gums are the following: (1) inaccurateimpression; (2) warped model. In a single office visit, there isgenerally no concern of intervening tooth movement or dental work sincethe impression and/or digital imaging was taken on the same visit.

The machine such as a thermo plastic machine, a vacuum forming machineor the like heats the sheets of plastic to encase the temporarilyattached first set of retention hooks, right and left, and the set ofbite pads integrated with the second set of retention hooks, right andleft.

Next, the trays are removed from the models by cutting with scissors, adental burr, or an exacto knife. The removal of the trays includes theencased first set of retention hooks and the set of bite pads integratedwith the second set of retention hooks from the models to form thedental appliance. The vacuum forming over the retention hooks encasesthe retention hooks and the bite pads.

The appliance created with plastic covering the 3D printed retentionhooks and covering 3D printed bite pads enables attachment of a pair ofelastic bands to be removably placed over the first and second sets ofencased 3D printed retention hooks to create a sleep apnea appliance, asshown in FIG. 4.

In one embodiment, the encased 3D printed bite pads can be altered byreleasably attaching at least two different sizes of snap-on bite padsof one or more thicknesses capable of snapping over the encased rightand left 3D printed bite pads to increase the amount of verticaldisplacement of the lower jaw when the oral appliance is worn.

A doctor or dentist can permanently secure the proper “snap on bite pad”by utilizing a thin mix of orthodontic acrylic or a thin mix of lightcure material. Place the prepared mix inside the dry “snap on bite pad”,right and left, and then push firmly over the dry incased bite padsright & left. There are two holes for excess material to escape throughthese holes so the “snap on bite pad” will be properly seated. The lowerappliance with its new snap on bite pads on right & left will need to becured if using acrylic or cured with a light gun.

In one embodiment, a computationally-implemented system for generating atrial oral appliance for sleep apnea, is provided using a threedimensional (3D) printing apparatus coupled to receive one or moredigital images of a patient's head, including one or more of upper andlower teeth. The 3D printer produces a 3D printed model of the patient'supper and lower teeth and one or more sets of 3D printed retentionhooks, and one or more sets of 3D printed bite pads.

In one embodiment, the 3D printer temporarily attaching a first set ofthe one or more 3D printed retention hooks to the 3D printed model ofthe patient's upper teeth. Next, the system temporarily attaches one ofthe sets of the 3D printed bite pads, wherein the set of the 3D printedbite pad is integrated with a second set of 3D printed retention hooksto the 3D model of the patient's lower teeth.

The 3D printer can be coupled to a vacuum machine such as that shown inFIG. 4 and can be coupled to a 3D printer to automatically place sheetsof plastic over the 3D models of the patent's upper and lower teeth withthe temporarily attached first set of 3D printed retention hooks and oneof the sets of 3D printed bite pads integrated with the second set of 3Dprinted retention hooks in a machine to form upper and lower plastictrays adapted to fit over the teeth of the patient, the machine enablingthe sheets of plastic to permanently encase the attached first set of 3Dprinted retention hooks and the set of 3D printed bite pads integratedwith the second set of 3D printed retention hooks.

In one embodiment the 3D printing system removes the trays from themodels with the encased 3D printed attachments such that the first setof 3D printed retention hooks and the set of 3D printed bite padsintegrated with the second set of 3D printed retention hooks from themodels form a trial dental appliance to enable attachment of a pair ofelastic bands to be placed over the first and second sets of encased 3Dprinted retention hooks.

Referring now to FIG. 7, a flow diagram illustrates a method inaccordance with an embodiment. Block 702 provides for temporarilyattaching a first set of three dimensional (3D) printed retention hooksto models of the patient's upper teeth. Block 704 provides fortemporarily attaching a set of 3D printed bite pads integrated with asecond set of 3D printed retention hooks to the model of the patient'slower teeth. Block 706 provides for placing sheets of plastic over themodels of the patent's upper and lower teeth with the temporarilyattached first set of 3D printed retention hooks and the set of 3Dprinted bite pads integrated with the second set of 3D printed retentionhooks in a machine to form upper and lower plastic trays adapted to fitover the teeth of the patient, the machine enabling the sheets ofplastic to permanently encase the attached first set of 3D printedretention hooks and the set of 3D printed bite pads integrated with thesecond set of 3D printed retention hooks. Block 708 provides forremoving the trays from the models with the encased 3D printedattachments such that the first set of 3D printed retention hooks andthe set of 3D printed bite pads integrated with the second set of 3Dprinted retention hooks from the models form the dental appliance toenable attachment of a pair of elastic bands to be placed over the firstand second sets of encased 3D printed retention hooks.

As will be appreciated by one of skill in the art, the 3D printer andvacuum machine can be integrated into a system that is computationallycontrolled with CAD technology and imaging equipment. In one embodimenta method of making a dental appliance for a patient includes retentionhooks for moving the lower jaw forward without bite pads. For example,the method includes temporarily attaching a first set of threedimensional (3D) printed retention hooks to models of the patient'supper teeth; temporarily attaching a second set of 3D printed retentionhooks to the model of the patient's lower teeth; placing sheets ofplastic over the models of the patent's upper and lower teeth with thetemporarily attached first set of 3D printed retention hooks and thesecond set of 3D printed retention hooks in a machine to form upper andlower plastic trays adapted to fit over the teeth of the patient, themachine enabling the sheets of plastic to permanently encase the firstset of 3D printed retention hooks and the second set of 3D printedretention hooks; and removing the trays from the models with the encasedfirst set of 3D printed retention hooks and the second set of 3D printedretention hooks from the models to form the dental appliance. The methodresults in a new oral appliance with permanently encased retention hooksthat were once temporarily attached, but via the vacuum forming of theplastic sheets become permanently encased.

While particular aspects of the present subject matter described hereinhave been shown and described, it will be apparent to those skilled inthe art that, based upon the teachings herein, changes and modificationsmay be made without departing from this subject matter described hereinand its broader aspects and, therefore, the appended claims are toencompass within their scope all such changes and modifications as arewithin the true spirit and scope of this subject matter describedherein. Furthermore, it is to be understood that the invention is solelydefined by the appended claims. It will be understood by those withinthe art that, in general, terms used herein, and especially in theappended claims (e.g., bodies of the appended claims) are generallyintended as “open” terms (e.g., the term “including” should beinterpreted as “including but not limited to,” the term “having” shouldbe interpreted as “having at least,” the term “includes” should beinterpreted as “includes but is not limited to,” etc.). It will befurther understood by those within the art that if a specific number ofan introduced claim recitation is intended, such an intent will beexplicitly recited in the claim, and in the absence of such recitationno such intent is present. For example, as an aid to understanding, thefollowing appended claims may contain usage of the introductory phrases“at least one” and “one or more” to introduce claim recitations.However, the use of such phrases should not be construed to imply thatthe introduction of a claim recitation by the indefinite articles “a” or“an” limits any particular claim containing such introduced claimrecitation to inventions containing only one such recitation, even whenthe same claim includes the introductory phrases “one or more” or “atleast one” and indefinite articles such as “a” or “an” (e.g., “a” and/or“an” should typically be interpreted to mean “at least one” or “one ormore”); the same holds true for the use of definite articles used tointroduce claim recitations.

The herein described aspects depict different components containedwithin, or connected with, different other components. It is to beunderstood that such depicted architectures are merely exemplary, andthat in fact many other architectures can be implemented which achievethe same functionality. In a conceptual sense, any arrangement ofcomponents to achieve the same functionality is effectively “associated”such that the desired functionality is achieved. Hence, any twocomponents herein combined to achieve a particular functionality can beseen as “associated with” each other such that the desired functionalityis achieved, irrespective of architectures or intermedial components.Likewise, any two components so associated can also be viewed as being“operably connected,” or “operably coupled,” to each other to achievethe desired functionality. Any two components capable of being soassociated can also be viewed as being “operably couplable” to eachother to achieve the desired functionality. Specific examples ofoperably couplable include but are not limited to physically mateableand/or physically interacting components and/or wirelessly interactableand/or wirelessly interacting components and/or logically interactableand/or logically interacting components.

While certain features of the described implementations have beenillustrated as disclosed herein, many modifications, substitutions,changes and equivalents will now occur to those skilled in the art. Itis, therefore, to be understood that the appended claims are intended tocover all such modifications and changes as fall within the true spiritof the embodiments of the invention.

What is claimed is: 1-21. (canceled)
 22. An oral appliance comprising:three-dimensionally (3D) printed upper and lower trays adapted to fittightly but removably over upper and lower teeth of a patient, the 3Dprinted upper and lower trays formed by a 3D printing apparatus coupledto receive one or more digital images of a patient's upper and lowerteeth, the 3D upper and lower trays, including: a first set of 3Dprinted retention hooks permanently encased by the 3D printed uppertray, the first set of 3D printed retention hooks permanently encased bythermoplastic material of the 3D printed upper tray; a set of 3D printedbite pads integrated with a second set of 3D printed retention hookspermanently encased by thermoplastic material of the 3D printed lowertray, each 3D printed bite pad having a bite surface which protrudestherefrom so as to engage the occlusal surfaces on the upper tray andthus maintain the occlusal surfaces of the trays in predetermined spacedrelation, when the trays are so fitted; and elastic bands configured toreleasably attach anterior and posterior portions of both sides of each3D printed tray by placing over the first set of 3D printed retentionhooks and the second set of 3D printed retention hooks to enable thelower jaw to advance forwardly when the upper and lower trays are fittedover the patient's teeth.
 23. The oral appliance of claim 22 wherein theelastic bands configured to releasably attach anterior and posteriorportions of both sides of each 3D printed tray include two or moredifferent lengths of elastic bands and two or more different strengthsof elastic bands.
 24. The oral appliance of claim 22 wherein the 3Dprinted lower tray includes a pair of snap-on bite pads of one or morethicknesses capable of snapping over the encased right and left 3Dprinted bite pads to increase the amount of vertical displacement of alower jaw when the oral appliance is worn.
 25. The oral appliance ofclaim 22 further comprising: one or more snap-on bite pads, the one ormore snap-on bite pads including one or more different thicknesses overthe encased 3D printed bite pads.